The following data is part of a premarket notification filed by Lee Pharmaceuticals with the FDA for 9075.
| Device ID | K760418 |
| 510k Number | K760418 |
| Device Name: | 9075 |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | LEE PHARMACEUTICALS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-08-09 |
| Decision Date | 1976-08-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() 9075 72465123 1001829 Dead/Expired |
LEE PHARMACEUTICALS 1973-08-08 |